NCT04623229已完成不适用
A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery
研究概览
简要总结
The focus of this study is to assess how pain can be mitigated for patients undergoing cataract surgery through the early application of anesthesia prior to the surgery as compared to the standard timing, and by using the ReLACS cataract surgery technique compared to the standard MCS technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing uncomplicated cataract surgery with either surgical technique (MCS or ReLACS)
- •Patients who require surgery in both eyes by same surgeon
- •Able to understand English and complete a pain assessment
排除标准
- •Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery
- •Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
- •Pre-existing uncontrolled glaucoma/high IOP
- •Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
- •Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
- •Patients under 40, severe obesity (BMI >35)
- •Chronic pain/narcotics/Recreational/medical marijuana
结局指标
主要结局
Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery
时间窗: 1 year
The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.
次要结局
- Differences in pain perception between first eye vs second eye(1 year)
- Effects of Early vs Standard administration of neurolept anesthesia on pain perception(1 year)
研究者
研究点 (2)
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